Cervical Cancer Care Reimagined: Is First-Line Treatment on the Verge of Transformation?

00:00:00:00 – 00:00:27:09
Unknown
Hello and welcome to today’s webinar, Cervical Cancer Reimagined: Is First-Line Treatment on the Verge of Transformation? I’m Aisha McClellan, cervical cancer coordinator at SHARE. Before the presentation begins, I’d like to tell you a little bit about SHARE. SHARE is a national nonprofit that supports, educates and empowers anyone diagnosed with breast or gynecologic cancers and provides outreach to the general public on signs and symptoms because no one should have to face breast, ovarian, uterine, cervical or metastatic breast cancer alone.

00:00:27:11 – 00:00:34:17
Unknown
For more information about our upcoming webinars, support groups and help lines, please visit. Please visit sharecancersupport.org.

00:00:34:17 – 00:00:41:23
Unknown
We are very excited to have Dr. Monk joining us today and I’d now like to hand it over to Dr. One to introduce himself.

00:00:42:12 – 00:01:17:10
Unknown
It’s great. Thank you. It’s my pleasure to be with you guys today. I’m a big, big fan of Share. As I no pun intended, share my screen. And it’s really a pleasure. And you guys do great work. And I’m just really honored to be hosted here. I’m very passionate about cervical cancer. As a young man, I was told that cervical cancer, when it recurs, was uniformly lethal and that it was not responsive to chemotherapy.

00:01:17:10 – 00:01:47:18
Unknown
And quite frankly, that made me angry, pissed me off. And so I have sort of devoted much of my adult life to proving that wrong. Also, as part of my journey I grew up in Arizona is that the Latino population there is really impacted. And so really before diversity was a thing, I became passionate about all women. I know that sounds crazy, but yeah, all women.

00:01:47:20 – 00:02:18:04
Unknown
And so I’m really a pleasure to be here. I’m in West Palm Beach. I have a couple of different jobs. There’s a nonprofit organization called the Jujuy Partners, which I founded in 2010. I continue to be the director of that, being passionate about cervical cancer. I chaired the Cervical Cancer Subcommittee for the National Cancer Institute, the NIH for 11 years, and also the Gynecologic Cancer Intergroup Cervical Cancer Committee.

00:02:18:06 – 00:02:47:16
Unknown
Now, I run clinical trials for the state of Florida, Florida Cancer Specialist and Research Institute, and I’m here in West Palm Beach. So I want to augment your knowledge. You wouldn’t be here if you didn’t have some knowledge. I want to share some of my tips. Again, I’m not always right, clearly, but I have treated a number of patients and I think I have some insight as to the best way to help women live better and live longer.

00:02:47:18 – 00:03:08:00
Unknown
It’s not enough to stay alive, but we have to keep ourselves safe and live well. And I want to equip you as well. So I thought I would start basic. I think that’s the best place to start is in the beginning. So what is the cervix? The cervix is part of the uterus. This is the body holds the baby.

00:03:08:02 – 00:03:39:12
Unknown
The cervix is the opening and this is the top of the vagina. And you can see here on a on a cartoon. Now I need to begin and say that cervical cancer should never happen, ever, because you can receive a vaccination against the virus, The human papillomavirus, which is almost 100% effective, and it can be given in young girls and boys before their sexual debut generally recommended around 11 or 12.

00:03:39:14 – 00:04:02:21
Unknown
But up to age 26, it’s been even reimbursed sometimes up to 45. And and and you can get screened in the way screens you look for the virus because you don’t have the virus, you’re not going to die of it. And certainly smoking and safe sexual practices now you have to have sex. But that’s not true to have a baby because I guess you could have it through artificial methods.

00:04:02:21 – 00:04:31:19
Unknown
But, you know, being promiscuous and sexually deviant is not associate with cervical cancer. It’s true that most women get it have had sexual relations, as has my mother, and at least twice because I have a brother. And there’s nothing ever that my mother could do wrong, in my opinion. So I just want to get that out there. My my residents and trainees call this a cauliflower lesion.

00:04:31:21 – 00:04:51:11
Unknown
This is looking into the vagina, but it’s cut out. This is a radical hysterectomy. A radical has direct me is more than a simple hysterectomy. People think radical means removal of the ovaries and fallopian tubes. No, what it is, is it’s removal of the upper vagina. You see this stuff and the pair of cervical soft tissue sometimes called the parametric them.

00:04:51:13 – 00:05:18:05
Unknown
This patient was cured with this operation. But you can see this and you’ll never eat cauliflower same again. This is the uterus again from a side use base cut in half. You can see this mass, which is every bit as large as the uterus here. White. This is the tailbone. This is the pubic bone. If you can just imagine cutting a patient and looking and this patient’s also cured.

00:05:18:07 – 00:05:42:09
Unknown
This cancer was too large for surgical resection. This is the bladder, this is the colon. The cervix is between the colon and the bladder space was also cured. But chemotherapy and radiation. Okay. It’s too big to cut out. Yeah. We prefer to avoid chemotherapy and radiation because it might have minor long lasting effects. That’s why this is the preferred method surgery for being early diagnosed.

00:05:42:11 – 00:06:22:17
Unknown
Now, this is an illness, a malady of international proportion. The number of cases in this country has remained relatively stable at about 14,000, with about 3 to 4000 deaths, because we can’t figure out how to get vaccinated. Okay. But the vaccine has been around since 2006 for 18 years. But what this shows that that say in North America and Europe, most patients are in the lower risk surgical opportunity, but in the locally advanced setting, where surgery’s not an option, let’s say 26% in Europe and 38% in North America where patients would need chemotherapy and radiation.

00:06:22:17 – 00:06:45:19
Unknown
So it’s more common internationally. Yes. And it’s more advanced stages internationally. So here in Africa, almost all the patients, 88% of the patients cannot have a surgery because it’s too big. Not that they would have the surgical expertise anyways in This also shows some Eastern European and Asian as well. But I just wanted to provide some of the demographics regarding this.

00:06:45:19 – 00:07:18:00
Unknown
Now, the discovery has been twofold is that when I looked at a cervical cancer as a young man, my professor said, Look, Munk, the way you tell that this is a cervical cancer is it’s bloody like, what do you mean? Well, the blood vessels are feeding the cancer. So I sort of had the opportunity working with my friends to show that if we could sort of interact with the vasculature, the angiogenesis and give an anti angiogenic that we could cure more patients.

00:07:18:02 – 00:07:42:24
Unknown
And then the second discovery that we made is that if we can teach the immune system to kill the cancer, we reprogram it. We could kill the cancer as well. So your immune system wants to kill your cancer, whether it be cervical cancer or other cancers, the immune cells wants to make this go away and we can give chemotherapy and radiation, but it’s not always effective.

00:07:42:24 – 00:08:19:12
Unknown
But if we can repro around the immune system through immunotherapy, and that has sort of been the epiphany, the discovery, the evolution and the name of this presentation. We’ve changed the world together. And in these studies, most of them have been through the nonprofit organization that I founded called the Georgi Partners Organization. That’s my backdrop. So I’m going to share with you clinical trials that women in their families supported, as well as pharmacy article companies because they have the medicines to cure more patients.

00:08:19:14 – 00:08:47:08
Unknown
So if I was to sort of boil it down on one slide, these are the six practice changing change the world phase three means we take what we’re doing and we randomize to a different treatment to help women live longer and live better. So in 1999, right after I finished my training, we showed that when radiation is given for an unresectable locally advanced cancer, that you can add platinum.

00:08:47:08 – 00:09:18:23
Unknown
Yes, the same metal that jewelry is made of, it can be soluble, lysed injected and it can bind to the DNA of the cancer cell and kill it and also make radiation work better. This was the first discovery phase. And then on behalf of the Go-Go’s, I had the honor of presenting the addition of cisplatin, which can be used in the recurrent setting, but also this medication called Taxol, which is from a conifer, the Pacific yew tree in the northwest Washington state, for example.

00:09:19:00 – 00:09:49:16
Unknown
And it’s part of the bark of the tree, which is part of the bark of the tree to protect it from the insects. look at that. And initially we cut down a lot of trees terribly and affected some squirrels. Not kidding. And then we got it from the pine needles and now it’s synthetic. And now the standard chemotherapy backbone since 2009 is platinum in a liquid form, cisplatin and paclitaxel, which used to be called Taxol, but now it’s generic.

00:09:49:18 – 00:10:27:21
Unknown
And then in 2014, we added an antibody that binds the hormone that makes the blood vessels grow. Bevacizumab changed the world again, and so it before 2009, patients were sort of living in the recurrent setting. And also about seven months we’ve been able to iteratively improve that what we call the front line, which is the title is patients who walk through the door and have A for B cancer, or they have persistent disease, they get radiated and it doesn’t go away or they have a surgery or radiation and it recurs.

00:10:27:23 – 00:10:50:18
Unknown
And all that is lumped into a term that I coined first line. Now, some people say, Well, what do you mean, isn’t chemotherapy and radiation first line? Well, there’s maybe and I’ll touch base on this a little bit, but generally by first line we mean stage four, be persistent or recurrent. Cervical cancer, which started out as chemotherapy and added an antibody to make the blood vessels not feed the cancer.

00:10:50:20 – 00:11:18:08
Unknown
Okay. And then ultimately immune therapy to help your immune system kill it. And then if that doesn’t work, published in the New England Journal, just on on January, on July 3rd, eight days ago, you can add now an antibody drug conjugate an antibody will stick to the tumor and bring on the back of the antibody, a payload of chemotherapy and enrich in the tumor microenvironment.

00:11:18:10 – 00:11:45:10
Unknown
A cytotoxic chemotherapeutic agent preferentially to the tumor. And that was published in the New England Journal on July 3rd, and that was FDA approved on an April 29th of this year. So these are really game changers. And now what happens is that again, the Georgi and my friends said, well, look, monkey, you know, you did all this work with immune therapy in recurrent, persistent or stage four.

00:11:45:10 – 00:12:17:07
Unknown
B, why don’t you add it to chemotherapy and radiation once you add it here? we did. You know, that was approved on January 12th of this year. So we’ve had two FDA approvals of an antibody drug conjugate in the second line chemotherapy and radiation in the curable setting. And then this was approved in 2021. This is what you call innovation and scientific process, scientific innovation and progress.

00:12:17:07 – 00:12:45:21
Unknown
I mean, as a team. So immune therapy actually started in the second line. We live in a country where we can get medications approved in an accelerated approval process. And what that means is that you can do a small study in this setting, 77 patients, and you can shrink tumors in a high unmet medical need and you can get it to the market here in in 2018.

00:12:45:23 – 00:13:08:22
Unknown
But the FDA says, look, that’s preliminary. You got to prove it. So we we got it approved in the second line as a single agent and then ultimately regular approval and with bevacizumab analysis said in January, Connecticut, chemotherapy and radiation, we have other immune therapies. I skipped over that slide, another one, which is a similar agent. It’s approved in other parts of the world.

00:13:08:24 – 00:13:35:03
Unknown
This particular agent is very common in the FDA, which is which is Japan. There are other immune therapies which are not approved just for the sake of time. I’m not going to get into them. But there are studies of durvalumab in a very nice, positive study of atezolizumab. So this is what I’m talking about. So again, when I was a younger man, I was told that cervical cancer was not sensitive to chemotherapy.

00:13:35:09 – 00:14:05:14
Unknown
And those women on average at an age of about 49, 50 with seven months with stage four, be persistent or recurrent seven months, 48 year old generally kids in the household. Then in 2004 I said, then we added paclitaxel and cisplatin. We’re able and I get at 7 to 12.9 is not enough. But we showed that we could actually shrink tumors in the recurrent setting 29% of the time.

00:14:05:17 – 00:14:41:12
Unknown
Again, not enough and we did not give up. So then we added this antibody that chokes off the blood vessels and we increased it from 12.9 to 17.5 and we almost doubled the response rate to 58%. This is 2014, 29, 2014, and then in 2020 it got better by adding and just piling on immunotherapy. And now the tumor shrinkage rate was 69% and patients were living more than two years.

00:14:41:14 – 00:15:07:17
Unknown
and then I discussed the publication on July 3rd of the antibody drug conjugate and the FDA approval on April 29th, and they can live another year after this. And so patients now with recurrent cervical cancer are living on average three years. And I’ll show you that we can actually cure them more often, which is our ultimate goal.

00:15:07:19 – 00:15:31:23
Unknown
So I’m going to sort of skip ahead for the sake of time. I want to leave time for you can download these slides and we’ll share them with you. These are the scientific data that go through all the curves and all of that, but it’s FDA approved and you can read about it in the New England Journal, which is the top medical journal in the world that added both bevacizumab in the recurrent setting and pembrolizumab.

00:15:31:23 – 00:15:52:13
Unknown
But I wanted to sort of put this into the real scenario. Okay. And this is a woman generally cervical cancers in age 50. But, you know, this woman hasn’t had a pap for for ten years. Why should she went through the menopause? She’s done having kids. Why go to the gynecologist? Well, because you might die from cervical cancer.

00:15:52:15 – 00:16:17:03
Unknown
If we’ve learned anything from Cope. If you don’t get vaccinated, you might die. And if you want to know what your risk is, get a COVID test. This is exactly what I’ve been trying to teach for decades. If you don’t get vaccinated, you’ll die cervical cancer or head neck cancer or penile anal and cancer, which are all HPV related facts.

00:16:17:05 – 00:16:38:15
Unknown
And if you want to know if you’re going to get it, get a viral test. So she has that and had a big tumor growing into the bladder and she can’t have it cut out. So what should she get? Chemotherapy and radiation and what should she really get? Well, since January and this is the I’m going to actually show you these curves.

00:16:38:20 – 00:17:09:12
Unknown
She should get immune therapy with it. FDA approved, reimbursed, recommended by the consensus guidelines. The consensus guidelines are called NCCN, National Comprehensive Cancer Network. And you can go on the NCCN website. You have to register. It’s free, and you can download the NCC and recommendations for any cancer, and so you can print them out or get them. There’s even an app and you can figure out what the best way is to treat cervical cancer.

00:17:09:16 – 00:17:43:17
Unknown
And the NCC says this patient needs chemotherapy, radiation, immune therapy, and it’s not being done. Why? It’s a great question. One of the challenges, you know, when you get a serious illness is that you go to someone that’s convenient, you go to someone that may or may not be expert. The most important decision that you’ll ever make if you get a serious illness is picking your doctor because your doctor will choose your treatment path.

00:17:43:19 – 00:18:09:20
Unknown
So this is the newest and the greatest. This is the last FDA approval that we had. This is January 12th, FDA approval. We took patients just like this hypothetical patient about a big tumor growing in her bladder and and treated her with cisplatin and radiation that we established in 1999. And randomized patients, a thousand patients around the world.

00:18:09:22 – 00:18:30:22
Unknown
Georgi in the Europe European friends which is called and got this and have got pembrolizumab in means therapy because we wanted to cure more patients. We had already showed in 2018 that it works in the second line we already showed and got FDA approval in 2021. That was the first line. Let’s give it with chemotherapy and radiation. It’s a no brainer, right?

00:18:30:24 – 00:19:00:09
Unknown
Well, that’s what I thought. And we want. And published in The Lancet. The Lancet is the New England Journal equivalent in the UK. I won’t go through the details other than to show that that when you look at these curves, these are called kaplan-meier curves. So in the beginning everyone’s alive. Times zero, everyone’s alive on percent, and over time patients die.

00:19:00:11 – 00:19:30:13
Unknown
Okay, And this is the placebo and this is chemotherapy and radiation alone. And this is the patients that got immune therapy called pembrolizumab, an antibody against PD-L1 or PD one. And if you compare this curve to that curve, this curve is 30% better. The dark timbre curve is 30% opposite the hazard ratio is points 0.7. So again, point seven minus one is point three or a 30% difference.

00:19:30:13 – 00:19:55:19
Unknown
So at any time along their disease course, you have a 30% chance of being alive versus dead if you get immunotherapy. Now, this is what the study showed. You may say this is not a big discriminator. And in fact, the FDA sort of felt that it would should be used in the highest risk patients and in the highest risk patients.

00:19:55:19 – 00:20:17:17
Unknown
The hazard ratio of 1.72.59. And this is the FDA indication. And if you if you read what I write or or follow the Georgi on Instagram or Twitter or LinkedIn, you’ll see that I’m pretty agitated about this because I wanted everybody that was eligible for the clinical trial. Listen, we studied it in this group of patients. It worked.

00:20:17:23 – 00:20:41:02
Unknown
Why are you going to slice of the pie? How dare you tell someone that you don’t have cancer? That’s bad enough to get the best treatment? Well, that’s what the FDA said. And so you have to have all the way invading the pelvic sidewall, blocking your kidney or like in our hypothetical patient, invading into your bladder or your rectum to get pembrolizumab.

00:20:41:04 – 00:21:18:05
Unknown
Since the FDA approval on January 12th. So there are side effects. The immune system that we’re educating can get so revved up that you can affect normal tissue, you can affect the lungs, You can even, you know, cause thyroid intestine and other even a rash. These severe adverse events happen around one in 25%. They can be reversed because if the immune system’s to active, get a little immunosuppression, calm things down.

00:21:18:07 – 00:21:50:16
Unknown
But this, I think, justifies the benefit moving forward. So back to our patient. This patient should get chemotherapy, radiation and pembrolizumab. Okay. So this is innovation. This is clinical trials. This is the Georgi this is working with a drug company. They have the medications. It’s not that we’re making all this money from the drug company, but we’re curing all these patients with the medications that are made by this particular medication.

00:21:50:18 – 00:22:18:23
Unknown
So I’m going to end a little bit more about me. I work for Florida cancer specialists. We have 100 offices in Florida. We have more than 270 doctors. Why does that matter? In each one of these dots is where there is an office in Florida, cancer specialists. Now, we’re not in Miami. We’re not in Fort Lauderdale or doctor on every corner, but we’re up in here up along the coast, Daytona.

00:22:19:00 – 00:22:51:05
Unknown
Okay. This is this is Tampa. There’s some unmet need in Orlando. Why is that important? That’s important because most of our patients live within 20 miles of our offices. Why does that matter? Remember, I’m going to come back to diversity, marginalized populations. Can’t we, through Jacksonville and get to the Mayo Clinic? In fact, the Mayo Clinic doesn’t even take Medicaid.

00:22:51:07 – 00:23:19:03
Unknown
But we do. And we’re woven throughout the fabric and we’re committed to research and we’re committed to seeing patients quickly with high quality. And I’m not trying to be negative to to the to the other practices in Florida, although we are the dominant practice. I’m trying to preach. Yes, preach that we need to bring medicine to the patient rather than have the met the patient get in the car and drive 2 hours.

00:23:19:05 – 00:23:47:03
Unknown
Yes. Even in rural America. Yes. Even if you’re a single mom? Yes. Even if you don’t speak English. And that’s my passion. And so we have hundreds of trials open. We enroll hundreds of patients. And that’s my passion. And I’m here to help anyone. This was there was no conflict of interest. I didn’t show you a conflict of interest line doing this for free.

00:23:47:05 – 00:24:15:23
Unknown
No one’s paying me to do this. And this is my passion and this is my life. And I really appreciate this opportunity. Thank you for having me today. Thank you so much. Your passion shines through and I just really appreciate all that you do. And I’m very grateful. Thank you. Let’s start the Q&A. There were a lot of questions and you can still submit questions in the Q&A section at the bottom of your screen.

00:24:16:00 – 00:24:41:13
Unknown
We’ll try to get through as many as we can with the remaining time, about 5 minutes. So let’s see, rapid fire questions. Do you consider any of the treatments currently used in cervical cancer treatment to do more harm than good? No. Okay. I mean, yes, there’s harm. Yeah, but you have to be alive to have a complication here.

00:24:41:17 – 00:25:13:00
Unknown
Every patient that’s dead never has a complication other than they died of their cancer. Now, if the treatment was killing the patient, that’s a different story. But these are not treatments that that have a death. It’s a risk for all intents and purposes. Right. How do newer treatments for cervical cancer compared to traditional chemotherapy, are they easier to tolerate under their antibodies?

00:25:13:02 – 00:25:46:13
Unknown
They’re not platinum. Heavy metals are poisonous. Ever heard of lead poisoning? Okay, so and the reason that your hair falls out with Taxol is because it kills rapidly growing cells such as your hair. So the targeted therapies are, we say are antibodies, all of them pembrolizumab, bevacizumab, even the antibody drug conjugate. So, yes. And so, as I said several times, our goal is yes, to cure more patients.

00:25:46:15 – 00:26:14:23
Unknown
But in addition to keeping them alive, we have to keep them safe and well right. What are the main challenges patients face with treatments, with current treatments for cervical cancer economics? So. So again, I’m from Arizona. About half of the patients in Arizona that get cervical cancer don’t have any funding from the county hospital in Phenix, doesn’t even have radiation.

00:26:15:00 – 00:26:44:03
Unknown
You don’t have to go to Africa to be treated in a hospital that doesn’t have radiation. Right. You just need to go to Phenix. So so our health care system is broken and we do not take care of the Americans or even those that are in America and they’re not underfunded. So that is the biggest challenge. The second biggest challenge is aligning yourself with the doctor that’s elite.

00:26:44:05 – 00:27:11:06
Unknown
I’m a sports fanatic. You know, there are there’s LeBron James and then there’s Don the Son Bronny. Okay. And and they’re different. And you have no idea when you go to your doctor whether your doctor is LeBron James or Bronny. James And so how do you know what you talk to your friends and I’m a big fan of specialty care so I have a sore shoulder.

00:27:11:06 – 00:27:34:19
Unknown
For example, if I ever get my shoulder operated on, I’m going to get my shoulder operated on by a world famous shoulder surgeon. I’m not going to go to the orthopedic surgeon that works around the corner because my shoulder is pretty important to me. Right? Right. But but but people think that every doctors do the same. Go ahead.

00:27:34:21 – 00:28:01:00
Unknown
Yeah. What do genetic tests have to do with my cervical cancer treatment? How might the personalize my care? So for all intents and purposes, cervical cancer does not run in families. You may say, Well, my sister got cervical cancer. You’re right. Because your sister has the same challenges in getting a pap test or getting vaccination or smoking or lives in rural America.

00:28:01:00 – 00:28:26:06
Unknown
All of those things. And they’re related, but it’s not genetic. So the short answer is nothing. Now, maybe you mean molecular markers. There are new treatments that are being developed, and in addition to what I described as a treatment paradigm, you should have in sort of the later line, your tumor profiles. It’s not the genes you were born with, but it’s the genes in the tumor.

00:28:26:08 – 00:28:47:20
Unknown
And we can sort of figure out some rare genetic mutations in the tumor. You weren’t born with them. You develop them so we can interact and kill your cancer. So again, that’s part of the standard treatment. I have time to get into that, but that’s what experts do. And so, for example, you should ask you to how many cervical cancer patients do you treat in a week?

00:28:47:22 – 00:29:18:08
Unknown
And if it’s not double digit run. Good point. Good point. Well, this this was great. last last question. Sorry. What is your biggest takeaway for patients? My biggest takeaway is, is get the best health care you can. The Affordable Cancer Affordable Care Act has been transformational. Everybody thinks they’re different, that they don’t need insurance until they do.

00:29:18:10 – 00:29:53:10
Unknown
And also see the best physician that you can see. I’m a gynecologic oncologist for one reason. Gynecologic oncologist, the only specialty in medicine that specializes in cancer. A radiation oncologist specializes in radiation. A medical oncologist specializes in medicines. I specialize in gynecologic cancer. I know more about cervical and ovarian cancer because I’m trained in it. It’s not that I’m smarter, but I trained in it.

00:29:53:12 – 00:30:19:12
Unknown
And. And I talk to my friends. So you can, whoever our listeners are surprised to hear. I live in Omaha, so I know, I know. I don’t know why. Omaha Robin Farias Eisner’s the chair of Creighton University’s again and it’s very good but but we’re we’re we’re at a club we’re a team and we all talk and we’ll do anything anything to help our women stay alive and live well.

00:30:19:21 – 00:30:36:12
Unknown
I love that. Thank you so much, Dr. Long, for an informative program. Thank you. Thank you. Thank you to everyone for participating and submitting questions. Please make sure to check out shares, upcoming educational programs and support groups and follow us on social media.

00:30:36:12 – 00:30:43:12
Unknown
This concludes the webinar. Thank you all so much. Thank you. Have a great day.